Application 214426

Type
ANDA
Sponsor
EYWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CITRATEPOTASSIUM CITRATETABLET, EXTENDED RELEASE;ORAL5MEQNoNo
002POTASSIUM CITRATEPOTASSIUM CITRATETABLET, EXTENDED RELEASE;ORAL10MEQNoNo
003POTASSIUM CITRATEPOTASSIUM CITRATETABLET, EXTENDED RELEASE;ORAL15MEQNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214426-001POTASSIUM CITRATEPOTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19
A214426-002POTASSIUM CITRATEPOTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19
A214426-003POTASSIUM CITRATEPOTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214426-001AB
A214426-002AB
A214426-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214426-002POTASSIUM CITRATE10MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214426-003POTASSIUM CITRATE15MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214426-001POTASSIUM CITRATE5MEQTABLET, EXTENDED RELEASE / ORALAB2021-02-198072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214426-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214426-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214426-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214426-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214426-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214426-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214426-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214426-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214426-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214426-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214426-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214426-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214426-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214426-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214426-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214426-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214426-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214426-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214426-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214426-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214426-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214426-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214426-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214426-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214426-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214426-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214426-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214426-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214426-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214426-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214426-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214426-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214426-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214426-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214426-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214426-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214426-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214426-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214426-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214426-001AB18072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CITRATEPOTASSIUM CITRATERising Pharma Holdings, Inc.164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca2026-07-14Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CITRATE
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackff67f638-5b53-406a-962a-87773a91fc482026-05-26Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEREMEDYREPACK INC.a9cc636d-3e26-450c-9df8-665d530d626f2026-04-06Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack6271d84e-d991-4bb8-ac9f-6d5cc879b6312026-03-25Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepack595343aa-b760-4158-9c49-dd5368f45e2c2026-03-25Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEANI Pharmaceuticals, Inc.2fb31727-68b1-4183-947d-00e08bf999872025-12-22Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEBiocomp Pharma, Inc.b32fe71a-4a58-04a1-64d3-bc3cc4a895bf2025-12-16Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackebf1f1f1-4458-4d34-8432-21698a550e072025-11-04Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack3dd9c9eb-df19-4ec9-bc77-f3a159b33d942025-10-23Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CITRATE
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepackb3ccba22-48cd-45f8-8c72-b80f34fe56be2025-10-23Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CITRATE
generic name: POTASSIUM CITRATE
POTASSIUM CITRATEPOTASSIUM CITRATEREMEDYREPACK INC.08c769d4-1dc0-4130-8f9c-cddace13a79b2025-09-12Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CITRATE
generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack44ab2c4f-4a76-470d-98fb-8874c692a9672025-08-20Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEUpsher-Smith Laboratories, LLC2215dc1d-0b5a-469e-9b51-4d7480a510782025-07-14Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEStrides Pharma Inc.5f38b02c-703c-4fc2-b833-654e41bd617f2025-07-01Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack8f5f7078-3c2d-406f-9222-b82a0f79d1682025-05-02Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepackb6ce81aa-ed9e-4eac-9f9c-26e2560f06db2025-05-02Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CITRATE
POTASSIUM CITRATEPOTASSIUM CITRATEBryant Ranch Prepack012c925e-5874-472b-a675-00bf79f649802024-12-24Warnings, Adverse reactionsName fallback
brand name: POTASSIUM CITRATE
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEAmerican Health Packaging1201c777-2388-4235-bb8f-eb7dc1e867f82024-09-03Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
Potassium CitratePOTASSIUM CITRATEBryant Ranch Prepackf2ab3c2e-2a6e-4698-afad-260bdf0d259e2024-08-06Warnings, Adverse reactionsName fallback
brand name: Potassium Citrate
generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASEPOTASSIUM CITRATEBryant Ranch Prepack9774b7c5-4695-47c9-9eb8-e0af2e05f5c32024-05-20Warnings, Adverse reactionsName fallback
generic name: POTASSIUM CITRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-3328Potassium-citpotassium-citREMEDYREPACK INC.ANDACurrent
71930-048Potassium-citPotassium-citEywa Pharma IncANDACurrent
71930-048Potassium-citPotassium-citEywa Pharma IncANDACurrent
71930-048Potassium-citPotassium-citEywa Pharma IncANDACurrent
71930-049Potassium-citpotassium-citEywa Pharma IncANDACurrent
71930-049Potassium-citpotassium-citEywa Pharma IncANDACurrent
71930-049Potassium-citpotassium-citEywa Pharma IncANDACurrent
71930-050Potassium-citPotassium-citEywa Pharma IncANDACurrent
71930-050Potassium-citPotassium-citEywa Pharma IncANDACurrent
71930-050Potassium-citPotassium-citEywa Pharma IncANDACurrent
72789-202Potassium CitratePotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-202Potassium CitratePotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-202Potassium citratePotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-203Potassium Citratepotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-203Potassium Citratepotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-203Potassium citratepotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-204Potassium CitratePotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-204Potassium CitratePotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-204Potassium citratePotassium citratePD-Rx Pharmaceuticals, Inc.ANDACurrent